POLYDEXA NASAL SPRAY
active substances: 1 ml solution contains neomycin sulphate 6500 IU, polymyxin b sulphate 10,000 IU, dexamethasone sodium metasulphobenzoate 0.25 mg, fenilafrina hydrochloride 2.5 mg;
excipients: methyl parahydroxybenzoate (E 218), lithium chloride, citric acid monohydrate, lithium hydroxide, macrogol 4000, Polysorbate 80, purified water.
Dosage form Nasal spray, solution.
Basic physical and chemical properties: transparent liquid.
Drugs used in diseases of the nasal cavity. Dexamethasone, combinations.
Code ATC R01A D53.
The therapeutic effect of the drug due to anti-inflammatory effect of dexamethasone on nasal mucosa, a vasoconstrictor effect fenilafrina and antimicrobial action of neomycin and polymyxin B. the combination of these antibiotics extends the spectrum of antimicrobial activity against most gram-positive and gram-negative microorganisms that cause infectious-inflammatory diseases of nasal cavity and paranasal sinuses. Due to the vasoconstrictor action fenilafrina reduced sensation of nasal congestion.
In polymyxin is active against Acinetobacter, Aeromonas, Alcaligenes, Citrobacter, Enterobacter, E. coli, Klebsiella, Moraxella, P. aeruginosa, Salmonella, Shigella, S. maltophilia.
To the action of polymyxin b resistant cocci and Bacillus, B. catarrhalis, Brucella, B. cepacia, B. pseudomallei, Campylobacter, C. meningosepticum, Legionella, Morganella, Neisseria, Proteus, Providencia, Serratia, V. cholerае El Tor Mycobacteria.
Neomycin is active against Corynebacterium, Listeria monocytogenes, Met-S Staphylococcus, Acinetobacter, B. catarrhalis, Campylobacter, Citrobacter, Enterobacter, E. coli, H. influenzae, Klebsiella, Morganella, Proteus, Providencia, Salmonella, Serratia, Shigella, Yersinia, Pasteurella.
To the action of Neomycin resistant Enterococci, N. asteroides, Met-R, Staphylococcus, Streptococcus, A. denitrificans, Burkholderia, flavo sp. P. stuartii, P. aeruginosa, S. maltophilia, chlamydia, Mycoplasma, Rickettsiae, resistant anaerobes
Studies of the pharmacokinetics of the drug were not conducted due to the low systemic absorption.
Indications: Inflammatory and infectious diseases of the nasal cavity, including acute rhinitis, acute sinusitis.
Children up to age 15 years;
hypersensitivity to any component of the drug, in particular to parabens or aminoglycosides;
history of stroke or risk factors that may contribute to the occurrence of stroke in connection with alpha simpatomimeticescoy activity of vasoconstrictors;
heavy and hard cured hypertension;
severe coronary insufficiency;
suspected angle-closure glaucoma;
a suspicion of urinary retention during urethro-prostatica violations;
infections nasal localization is caused by the herpes simple or herpes zoster, varicella;
cramps in the anamnesis;
concomitant use with nonselective MAO inhibitors due to risk of paroxysmal hypertension and hyperthermia (see section "Interaction with other medicinal products and other forms of interaction");
the simultaneous use of other indirect sympathomimetics and alpha-sympathomimetics, regardless of the route of application oral or nasal, through the risk of vasoconstriction or hypertension (see section "Interaction with other medicinal products and other forms of interaction").
Interaction with other medicinal products and other forms of interaction
Following are the features of the interaction of drugs occurs in systemic distribution of the active ingredients of the drug.
The interaction associated with fenilafrinom
with non-selective MAO inhibitors irreversible action: the risk of paroxysmal hypertension, hyperthermia, which can be lethal. Due to the long-acting MAO inhibitors interactions possible within 2 weeks after discontinuation of MAO inhibitors.
other indirect sympathomimetics and alpha sympathomimetics (oral and/or nasal): risk of vasoconstriction and/or hypertensive crisis.
with ergot alkaloids dofaminergical and vasoconstrictor ergot alkaloids: risk of vasoconstriction and/or hypertensive crisis;
with selective MAO inhibitors and reverse actions, including linezolid and methylene blue: risk of vasoconstriction and/or hypertensive crisis.
Combination, requiring careful use:
galogennye with volatile anesthetics: peroperative hypertensive crisis. In the case of a planned intervention, it is desirable to interrupt treatment for a few days before surgery.
The interaction of FL 'associated with dexamethasone
with acetylsalicylic acid: increased risk of bleeding while the use of anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per intake or ≥ 3 g per day).
Combination, requiring careful use:
with aminoglutetimidom: increased activity of dexamethasone (through increasing its metabolism in the liver). A correction dose of dexamethasone;
drugs that can cause polymorphic ventricular tachycardia type "pirouette": particolare increased risk of arrhythmias, including polymorphic ventricular tachycardia type "pirouette". Before treatment to assess the presence of hypokalemia, and to determine blood serum potassium and ECG;
with other drugs that lower the level of potassium in the blood (Gokulam diuretics alone or in combination, laxatives, intravenous amphotericin b, glucocorticoids, and tetracosactide): increased risk of hypokalemia through an additive effect. Hypokalemia is a contributing factor in cardiac arrhythmias (especially polymorphic ventricular tachycardia type "pirouette") increases the toxicity of certain drugs. Should monitor blood serum potassium and correct it if necessary;
with digitalis preparations: hypokalaemia exacerbates the toxic effects of digitalis drugs. Before treatment to assess the presence of hypokalemia, and to determine blood serum potassium and ECG;
with anticonvulsants, inducers of the synthesis of enzymes: reduction in the plasma concentration and the efficacy of corticosteroids by enhancing their metabolism in the liver. The consequences are particularly severe (or significant) for patients with Addison's disease who are treated with hydrocortisone, and in the case of organ transplantation. The necessary monitoring of clinical and laboratory research, as well as correction doses of corticosteroids during combined therapy and after cessation of treatment with inducers of enzyme synthesis;
with praziquantel: decrease in plasma concentrations of praziquantel, with subsequent risk of treatment failure by enhancing its metabolism in the liver. Split time taking these medications with a pause of at least one week.
Combinations that require attention:
with antihypertensive drugs: possible attenuation of the antihypertensive effect (the content in the body of salt and water due to the influence of corticosteroids);
with clarithromycin, erythromycin, ritonavirboosted protease inhibitor, Itraconazole, ketoconazole, nelfinavir, Posaconazole, telithromycin, voriconazole: increased concentrations of dexamethasone in plasma by decreasing its metabolism in the liver due to the inhibition of enzymes, with the risk cushingoid syndrome;
with acetylsalicylic acid: increased risk of bleeding from antipiretico or anaesthetic doses ≥ 500 mg per intake and / or < 3 g per day;
non-steroidal anti-inflammatory drugs: increased risk of peptic ulcer disease and bleeding of the gastrointestinal tract;
with ftorlon: possible increased risk tendinitis or even tendon rupture (rare), particularly in patients who were treated long-term with corticosteroids.
The drug should not be swallowed.
Do not use the medicine more than the prescribed period. Not recommended to use the drug for a long time because of the risk of withdrawal syndrome and iatrogenic rhinitis. Repeated and/or prolonged inhalation may cause systemic absorption of active substances.
The presence of corticosteroid in the composition of the drug does not prevent local symptoms of allergies, but can change their course.
The injection is carried out by pressing the bottle. In applying the drug to keep the vial upright and the head slightly tilted forward in order to inject the nasal passage solution in the form of a spray, not a jet of liquid.
The drug does not apply to children under the age of 15 years.
Provided long-term treatment (more than the deadline), or the application of doses, greatly exceeding recommended, the drug may cause systemic effects: hypothermia, sedation, loss of consciousness, coma and respiratory depression.
Associated with the presence of antibiotics:
possible systemic or local allergic reactions (redness, swelling) and sensitization to antibiotics, the composition of the drug, which may hinder the following technique similar or related antibiotics.
Associated with the presence of fenilafrina:
palpitations, tachycardia, myocardial infarction.
From the side of organs of vision:
the crisis of angle-closure glaucoma.
The gastro-intestinal tract.
dry mouth, nausea, vomiting.
From the nervous system:
hemorrhagic stroke, particularly in patients who have used the tools with pseudoephedrine hydrochloride; zerebrovskulyarnoe this event occurred in the treatment with excess doses or incorrect application of the patient who had the vascular risk factors; ischemic stroke, headache, seizures.
anxiety, agitation, abnormal behavior, hallucinations, insomnia.
Fever, causes which can be overdose or combination of drugs, which differ in the interaction or overdose.
With the genitourinary system:
dysuria (in case of existing diseases of the urethra or prostate), urinary retention (particularly in diseases of the urethra or prostate).
From the leather side:
sweating, rash, pruritus, urticaria.
hypertension (hypertensive crisis).
Disorders at the injection site: dry nose, liquid Allergy symptoms.
Shelf life. 3 years.
Storage conditions. Keep out of reach of children at temperature not exceeding 25 °C.
Packaging. 15 ml bottle with sprayer in a cardboard box.